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Kandungan disediakan oleh Darshan Kulkarni. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Darshan Kulkarni atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
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Off-Label Risks: Compliance Matters Now More Than Ever

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Manage episode 421766467 series 3506216
Kandungan disediakan oleh Darshan Kulkarni. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Darshan Kulkarni atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.

We discuss the following:

  1. What does off-label mean from a reimbursement standpoint?
  2. Lessons from the US v. Eli Lilly 2009 case
  3. How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau
  4. How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid?
  5. How are compounded drugs reimbursed?
  6. Could a company be held accountable for off-label use of a drug due to
  7. compounded products?
  8. Are weight loss drugs exempted from reimbursement?

Support the Show.

  continue reading

84 episod

Artwork
iconKongsi
 
Manage episode 421766467 series 3506216
Kandungan disediakan oleh Darshan Kulkarni. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Darshan Kulkarni atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.

We discuss the following:

  1. What does off-label mean from a reimbursement standpoint?
  2. Lessons from the US v. Eli Lilly 2009 case
  3. How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau
  4. How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid?
  5. How are compounded drugs reimbursed?
  6. Could a company be held accountable for off-label use of a drug due to
  7. compounded products?
  8. Are weight loss drugs exempted from reimbursement?

Support the Show.

  continue reading

84 episod

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